Eli Lilly & Company: Drug Recall

Recall #D-0009-2022 · 09/24/2021

Class I: Dangerous

Recall Details

Recall Number: D-0009-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Eli Lilly & Company
Status: Terminated
Date Initiated: 09/24/2021
Location: Indianapolis, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19,174 syringes

Reason for Recall

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

Product Description

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01

Distribution Pattern

Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico

Other Recalls by Eli Lilly & Company

Class II: Risk 03/12/2024

CGMP Deviations
Class II: Risk 08/19/2021

Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class II: Risk 06/29/2021

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

View all recalls by Eli Lilly & Company →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.